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DENTCA Design DENTCA Design - Pala Design Studio

by Dentca, Inc.

DENTCA Design DENTCA Design - Pala Design Studio is a CAD/CAM software (FDA Class II; FDA product code NOF) made by Dentca, Inc., listed in FDA GUDID since 29 Oct 2021 (UDI-DI 00856551007513), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00856551007513 UDI-DI Date29 Oct 2021ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
DENTCA Design
Generic name
CAD/CAM software
Model / reference
DENTCA Design - Pala Design Studio
Primary DI / UDI-DI
00856551007513
FDA product code
NOF
GMDN term
CAD/CAM software
Device class
Class II
Regulation number
872.3661
GUDID distribution status
In Commercial Distribution

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Properties

  • Premarket exempt
Other properties (14, all answered No)